Table 3.
IRLS Scale | Baseline | Month 4 | Month 12 | Global P |
---|---|---|---|---|
Global score | ||||
per-protocol subcohort | 18 (16, 21) | 13 (10, 16) | 11 (8, 15) | 0.001 |
ITT subcohort | 19 (17, 21) | 14 (12, 17) | 14 (11, 17) | <0.0001 |
Symptoms severity subscale | ||||
per-protocol subcohort | 12 (11, 14) | 8 (6, 11) | 8 (6, 10) | <0.001 |
ITT subcohort | 13 (11, 14) | 9 (8, 11) | 9 (8, 11) | <0.0001 |
Impact on daily living subscale | ||||
per-protocol subcohort | 3 (3, 4) | 3 (2, 4) | 2 (1, 3) | 0.05 |
ITT subcohort | 4 (3, 5) | 3 (3, 4) | 3 (2, 4) | 0.003 |
The data are presented as adjusted means (95% confidence interval). Adjustment variables include use of RLS medications (at any time for per-protocol analysis and at baseline for ITT analysis), time, and interaction of these two variables. The per-protocol subcohort includes 46 participants, and the ITT subcohort includes 94 participants who had RLS at baseline. The global P values are based on testing time (baseline, month 4, and month 12) as a fixed effect from repeated measures analysis of covariance. P < 0.02 for pair-wise comparisons of baseline versus month 4 and month 12 for the IRLS global score and its two subscales (in both per-protocol and ITT subcohort), with the exception of the impact on daily living subscale comparison of baseline versus month 4.